Our company name, OR-6, is a reference to the operating room where the Surgi-Sign was first used clinically. When Dr. Goolishian was the chief of Anesthesia at the Cape Cod Hospital, a surgeon accidentally harmed a patient by operating on the wrong side of the body. The committee responsible for conducting the Root Cause Analysis determined that the wrong side of the patient’s body had been incorrectly marked prior to surgery.
Dr. Goolishian was on this committee and was shocked to learn that this type of error actually occurs at least 40 times a week in the United States. Worldwide, it is estimated that 10,000 wrong-site errors happen each year.
What was most alarming to Dr. Goolishian was the committee’s inability to address this persistent problem in a meaningful way. This led to Dr. Goolishian conducting a Six Sigma analysis of the entire surgical site marking process, from the pre-operative marking to the Time Out conducted in the operating room just prior to incision.
The results of this study led to the creation of the Surgi-Sign, a temporary tattoo that is applied in the surgical field prior to surgery. This tattoo is a simple, visual checklist that is designed for the entire team to use as an important communication tool, showing that everyone has confirmed and agreed to the correct surgical site.
What distinguishes this marking system is that the boxed areas contain no tattoo film or adhesive, which means all surgical marks are written directly on the patient’s skin. All of this is done in the Pre-Op holding area. Later, inside the operating room and prior to site prepping and the Time Out, the yellow tattoo material is wiped away within 15 seconds, but all of the team’s marks remain visible on the skin.
OR-6 has grown and is supported by people who are deciated to raising awareness about patient safety issues. Their innovative product, the Surgi-Sign, addresses wrong-site surgical errors. We are passionate about the elimination of all needless medical errors and the harm to patients and their families. Read more about their story below.
PRE-OP – Fully-crosschecked Surgi-Sign.
OR – After Surgi-Sign has been wiped away you’re ready for prepping and your Time Out.
Wrong-site surgeries: limited accountability
The Joint Commission is a not-for-profit organization that sets rigorous standards for patient safety and healthcare quality in the United States. They inspect and accredit most hospitals and surgical centers in this country.
Joint Commission data reveals that over the past 15 years, wrong-site surgeries have remained consistently one of the top three errors hospitals report to them. However, a problematic calculus inherent in their statistics is that many states do not require their hospitals to report wrong-site errors. Thus, the actual number of wrong-site surgeries that occur each year in the U.S. is unknowable.
“As many as 50 wrong-site surgeries per week”
The President/CEO of The Joint Commission published an article in Health Affairs stating that he believes “there may be as many as fifty wrong-site surgeries per week in the United States.”
For hospitals, the magnitude of a wrong-site surgical error leads many to vastly under-report or even suppress occurrences. A study of U.S. malpractice claims revealed that “wrong-site procedure surgery is associated with a 13.9% mortality, and 55.0% permanent injury rate.”
One wrong-site surgery can cost a hospital up to $3M in penalties, malpractice payments, and the cost of care to repair the damage. Since these medical errors are indefensible, hospitals choose to settle with the patient quickly and quietly.
From a malpractice perspective, wrong-site surgeries are de facto indefensible and the claims are automatically paid. When wrong-site surgery cases manage to get some media attention, this is due largely to the fact that the victim has chosen to go to trial instead of taking a cash payout. Otherwise, those involved remain silent.
It happens to good surgeons too
Most hospitals in the U.S. can expect to have at least one wrong-site error every three years. Too many people assume, sadly, that these errors are limited only to small community hospitals and they only happen to bad surgeons. Data proves this is not the case. These errors happen at the Mayo Clinic, Cleveland Clinic, Johns Hopkins Hospital, and other well-respected hospitals in the United States. Dr. David C. Ring, a surgeon at Massachusetts General Hospital, published an article in the New England Journal of Medicine admitting that he performed an “incorrect operation.” His honesty and willingness to address the topic of wrong-site surgeries is admirable; but, unfortunately, most hospitals and surgeons are not as forthright.
Airline Industry’s Visual Crosschecks
The solution to prevent wrong-site surgical errors came from an unexpected source. Dr. Goolishian and Dr. Thorpe were on an airplane leaving for a medical conference shortly after his hospital’s Root Cause Analysis determined the surgeon marked the wrong side of a patient prior to surgery. They were in the middle of discussing his hospital’s weak plan to “prevent” another wrong-site surgery when the flight crew announced that the doors were armed and the crosschecks had been completed.
During the flight they asked an attendant for more information about this process. The attendant explained that when crew members lock and arm each door, inside a small plastic window, a visual reference flag changes from a red “unlocked” indicator to a green “locked” one, confirming the door was secured correctly. Next, each crew member looks across the cabin to crosscheck and confirm, visibly, that the other doors were properly secured.
The idea of “boxes” changing on the patient’s skin for everyone to visually confirm the correct site, was exactly what was needed. From that flight the Surgi-Sign was born.
A mission-driven company
Dr. Thorpe and Dr. Goolishian personally know a woman who had been looking forward to her retirement days of golfing in Florida with her husband. They had already purchased a condo adjacent to a golf course and her husband was learning to fly so that they could travel easily between their home state of Rhode Island and Florida.
However, one day a very good surgeon operated at the wrong spine level on this woman. After months of severe nerve pain that was getting worse, not better, she finally learned of the surgical error. By this time, unfortunately, the nerves in her lower back had become permanently damaged.
She could no longer golf, and sitting for a few hours in a plane caused too much pain. This couple sold their condo, stopped golfing and flying, and she is now left with a lifetime of pain management. Her story never made it into the news.
Dr. Thorpe and Dr. Goolishian are on a mission to prevent wrong-site surgeries
Dr. Goolishian knew, based on decades of clinical experience, that a truly viable solution to this problem needed to be simple, inexpensive, and adaptable if clinicians were going to incorporate it into their fast-paced workflow.
Visual Crosschecks: Surgi-Sign
While keeping the successful airline safety measures in mind, Dr. Goolishian and Dr. Thorpe created a product that included teamwork, standardized marks, and a simple, visual checklist that stayed with the patient throughout the entire surgical process. Together they invented and designed a novel temporary tattoo: the Surgi-Sign.
Their unique tattoo marking system prompts the surgeon to write his/her initials in the operative site, and the patient, nurse, and anesthesiologist to confirm with a checkmark that the correct surgical site has been identified.
But the truly innovative part is that when the tattoo is wiped away in the operating room, prior to prepping the surgical field, the surgeon’s initials and team checkmarks remain visible on the skin to clearly indicate where the incision should be made.
This methodology far exceeds current best practices for hospitals and the recommended protocols from accrediting organizations like The Joint Commission.
The Surgi-Sign successfully prevents costly wrong-site errors through a simple, inexpensive technology that is intuitively easy to use. It requires little training, and it can be integrated into the pre-procedure verification process with no disruption to workflow.
With the Surgi-Sign there is documented proof of improved compliance with all of the required elements in The Joint Commission’s Universal Protocol: standardized site markings, patient involvement, and ensuring surgical markings are visible in the surgical field before the time-out.
The Surgi-Sign appeals to the whole surgical team—including the patient. Surgeons benefit from the added protection of having patients mark themselves. Nurses play a more active role, and anesthesiologists can confirm the correct operative site before performing a block. Patients now feel safer by taking an active role in their own surgical care.
This methodology proved to be enormously successful in the airline industry. Despite the wide variety of aircraft and changing crew members, this universal, visual crosscheck system prevented inadvertent human errors that could cause devastating human consequences, and it saved the airline industry millions of dollars.
Drs. Goolishian and Thorpe realized the best solution to prevent wrong-site surgical errors must include visual indicators that could show clearly to everyone the correct surgical site had been identified and crosschecked by the entire surgical team.
Dr. Tracy Thorpe, Ph.D.
Co-Founder & CEO
Dr. Tracy Thorpe is the Co-Founder and CEO of OR-6, a patient safety medical device company. She became passionate about patient safety advocacy after a friend of hers was permanently injured due to an wrong-site surgery accident. Since then, she has talked with many patients and families who have experienced unnecessary medical errors. Dr. Thorpe’s goal is to help spread awareness and prevent these types of accidents from happening in the future.
Dr. Thorpe holds a Ph.D. from Harvard University, a Master’s degree from Harvard Divinity School, and a Bachelor’s degree from UCLA, where she graduated cum laude. Dr. Thorpe has received numerous awards and honors from both Harvard and UCLA. Dr.
Prior to earning her doctorate, Dr. Thorpe worked as a contractor for the U.S Department of Defense for six years in the Force Protection group conducting security and risk analyses worldwide. Prior to that, she worked for 10 years at Bankers Trust Company in Los Angeles where she held positions in information technology.
Dr. Wade Goolishian, M.D.
Co-Founder, Inventor, and COO
Dr. Goolishian invented the Surgi-Sign and has been granted two patents for this product (USPTO 8,636,708 and 9,827,049) for his recent invention, the Surgi-Sign Marking System.
Dr. Goolishian graduated from Vassar College with an A.B. in Biochemistry and an M.D. from Tufts University. He did his residency training in surgery, critical care, and anesthesiology at Baystate Medical Center and is a diplomate of the American Board of Anesthesiology. He has been a practicing anesthesiologist for twenty-five years in both academic and community hospital settings, and he is currently a partner at Cape Cod Anesthesia Associates. Dr. Goolishian has served as the Chief of the Department of Anesthesiology at Cape Cod Hospital and has been a member of several hospital committees including the Operating Room Committee, Medical Executive Committee, Process Improvement Committee, and the Credentials Committee.
Throughout his career, Dr. Goolishian has received several awards including the national award for outstanding research during residency training from the Society of Critical Care Medicine and he has several publications related to his research in both basic science and medical devices.
Dr. Goolishian also holds a Black Belt in Six Sigma process improvement from the Aveta Business Institute.
Susan Thorpe, R.N.
Research and Events Coordinator
Ms. Thorpe is a research nurse at OR-6 and assisted in Phase 1 clinical trials for the Surgi-Sign. She is also responsible for organizing national nursing and physical conference exhibitions, and she provides support for marketing and sales efforts.
Ms. Thorpe is a registered nurse whose compassion and caring led her to become a strong, tireless advocate for patient safety. Currently she works Utah’s Intermountain Healthcare in the St. George Regional Hospital and spent many years working in the Orthopaedic unit. There she provided post-surgical care for joint replacement and spine surgery patients. Prior to that she worked in the cardiovascular and oncology units. Ms. Thorpe graduated from Dixie State University in St. George, UT with an Associate of Science in Nursing, after which she became a Registered Nurse.
We’re excited to share our Surgi-Sign products with you. We believe that what happens before the Time Out is just as important as the Time Out itself. Surgi-Sign is your best method to eliminate wrong-site surgeries at your hospital.
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